ALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A1
Ref 102-0101-002
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D735CompositeP6 +D73510201010020 | Date25 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Restorative Composite
- Model / Reference
- 102-0101-002
- Primary DI / UDI-DI
- +D73510201010020
- Basic UDI-DI
- ++D735CompositeP6
- EMDN Code
- Q01010103 Dental restorative composites
- Device Class
- Class IIa
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- US-MF-000027130
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Dental Technologies, Inc.
Properties
Other properties (12)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No